Novan Provides Update on SB414 Inflammatory Skin Disease Development Program
SB414 – Nitric Oxide-Releasing Cream – Safe and Well-Tolerated in Psoriasis Phase 1b Trial
Preclinical Data with SB414 Targeting Key Inflammatory Cytokines IL-4 and IL-13 in Atopic Dermatitis
to be presented at International Investigative Dermatology Meeting
Psoriasis—Phase 1b Clinical Trial Complete
SB414 was evaluated in a Phase 1b multi-center, double-blind, randomized, vehicle-controlled trial conducted in 36 male and female patients, ages 18 to 70, with mild-to-moderate chronic plaque psoriasis. Patients were treated with SB414 6% or vehicle cream twice daily for four weeks and evaluated for safety and tolerability. At the end of the four-week treatment period, samples were collected for pharmacokinetic (PK) and pharmacodynamic (PD) analyses.
Preliminary topline results and next steps:
- SB414 was found to be safe and well-tolerated in the trial.
- The Company is continuing to analyze the PK (systemic exposure) and PD (a panel of inflammatory biomarkers) data from the trial; potential further analyses will enable the generation of additional data and associated learnings regarding patient characteristics (e.g., gender/age), disease progression (treatement-naïve, mild, moderate), co-morbidities and others.
- Complete results and analyses, as well as initial conclusions and potential next steps regarding SB414 and the inflammatory skin disease program using the underlying nitric oxide technology, will be reported following completion of the complementary atopic dermatitis trial and subsequent data generation, as previously communicated.
“The Phase 1b trial with SB414 in patients with psoriasis was our first experience with SB414 cream in the clinic, and it has shown a safe and tolerable profile similar to the profiles of SB204, SB206 and SB208,” stated
Atopic Dermatitis—Phase 1b Clinical Trial Fully Enrolled
A Phase 1b trial is being conducted in 48 male and female patients, ages 18 and older, with mild-to-moderate atopic dermatitis covering up to 30% body surface area at baseline. Patients are receiving two doses of SB414 cream or vehicle, applied twice daily for two weeks. As with the Company’s Phase 1b trial in psoriasis, the primary objective of this exploratory trial is to better understand SB414’s safety and tolerability, possible systemic exposure and activity against inflammatory biomarkers in patients with atopic dermatitis.
The Company is pleased to report that the trial has fully enrolled and continues to target receipt of initial topline results in the third quarter of 2018. Complete results and analyses from both the psoriasis and atopic dermatitis trials are targeted to be reported in the second half of 2018, along with potential next steps for SB414 and the inflammatory skin disease program.
Atopic Dermatitis—Preclinical Study Data to be Presented at International Investigative Dermatology Meeting
Importantly, as part of the Company’s continued work around its nitric oxide platform and the platform’s mechanistic application to inflammatory skin diseases, the Company will be highlighting data from preclinical studies with SB414 during a presentation at the upcoming International Investigative Dermatology meeting held
An atopic dermatitis mouse model, which had previously been used to correlate the role of Staphylococcus aureus in the upregulation of inflammation, demonstrated that topically applied 6% SB414 cream reduced pro-inflammatory cytokines IL-4 and IL-13 by 87% and 76%, respectively, over vehicle. The Staphylococcus aureus levels in the skin of SB414-treated mice were also reduced by greater than 90% over vehicle-treated mice.
“In the management of atopic dermatitis, the ability to directly target pro-inflammatory cytokines that perpetuate the disease, like IL-4 and IL-13, is key for sustained benefit,” stated
About the Presentation
Abstract Number: LB1571
Title: “Effects of SB414 Cream on S. aureus and tissue cytokines in an atopic dermatitis mouse model”
Authors: S. Hollenbach, T. Nakatsuji, R. Gallo, N. Stasko
Date and Time:
Psoriasis is a chronic inflammatory skin disease that affects approximately 7.5 million people in
There is no cure for psoriasis.3 The healthcare market has seen an increase in the introduction of systemic therapies, including biologics, to treat patients with higher disease burden, but all of the current systemic therapies are indicated only for patients with moderate-to-severe disease. For the approximately 80% of patients with mild-to-moderate psoriasis, prescription treatment options include topical corticosteroids, retinoids and vitamin D3.1,2 None of the currently approved therapies are without side effects, and none are well-suited for chronic use.2,3
About Atopic Dermatitis
Atopic dermatitis, also known as atopic eczema, is the most common chronic relapsing inflammatory skin disease, affecting nearly 18 million people in
Nearly eighty percent of the atopic dermatitis population suffers from mild-to-moderate disease and are treated with first-line monotherapies, however, corticosteroids and calcineruin inhibitors have side effects and are not well-suited for chronic use.4 Recently, the first biologic treatment for atopic dermatitis targeting IL-4 and IL-13 was approved, but it is reserved for patients with moderate-to-severe disease. A topical phosphodiesterase-4 (PDE4) inhibitor was also recently approved after more than a decade of absence of therapies representing a new mechanism of action.
3 Vaidya T, Feldman SR, Kirk J. Patient-centered approach to biologics in the treatment of psoriasis.
4IMS Health Disease Insights. “Atopic Dermatitis – US.”
5Higaki S., et al. Int J Dermatol. 1999. 38, 265-269.
6Gong J.Q. et al. Br J Dermatol. 2006. 155(4), 680-687.
7Nakatsuji T., et al. J Invest Dermatol. 2016. 136(11):2192-2200.
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates, our potential partnership opportunities, and the future prospects of our business and our product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research or trials and other risks and uncertainties described in our annual report filed with the
Director, Corporate Communications and Administration